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Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04357327
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Lorenzo Azzi, Università degli Studi dell'Insubria

Brief Summary:

The present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program.

The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100.

The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis.

Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available.

The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).


Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV 2 Corona Virus Infection Diagnostic Test: rapid salivary test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Consecutive recruitment of both patients with COVID-19 like symptoms (i.e., cough, fever, dyspnea) and patients with low risk phenotype
Masking: Single (Outcomes Assessor)
Masking Description: The rapid salivary test will provide results within 5-10 minutes, while the rRT-PCR performed on nasopharyngeal swab shows results only after 6 hours, thus the outcome assessor of the experimental test is blinded
Primary Purpose: Diagnostic
Official Title: Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19): a Diagnostic Accuracy Study
Actual Study Start Date : April 16, 2020
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Symptomatic patients
Patients with symptoms associated with COVID-19, i.e., dyspnea, cough, fever, etc.
Diagnostic Test: rapid salivary test
a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay

Active Comparator: Asymptomatic subjects
Asymptomatic patients with low risk phenotype, that means patients with a previous negative swab, no relatives affected by COVID-19 and with reduced social interaction within the last two weeks.
Diagnostic Test: rapid salivary test
a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay




Primary Outcome Measures :
  1. Sensibility [ Time Frame: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; sensitivity recorded through study completion, an average of 2 months. ]
    TP/TP+FN (TP= True Positive; FN = False Negative)

  2. Specificity [ Time Frame: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; specificity recorded through study completion, an average of 2 months. ]
    TN/TN+FP (TN= True Negative; FP= False Positive)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

People who undergo nasopharyngeal swab to confirm or exclude SARS-CoV-2 infection

Exclusion Criteria:

none


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357327


Locations
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Italy
ASST dei Sette Laghi
Varese, VA, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Lorenzo Azzi Università degli Studi dell'Insubria
Study Data/Documents: Scientific paper  This link exits the ClinicalTrials.gov site
Identifier: 10.1016/j.jinf.2020.06.042

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Responsible Party: Lorenzo Azzi, Assistant Professor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT04357327    
Other Study ID Numbers: 68/2020
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We could provide anamnestic, clinical and serological data of each participant at the end of the study, or at least at the end of the first phase.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Data will be available at the end of the study, once statistical analyses is conducted
Access Criteria: Contact Principal Investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lorenzo Azzi, Università degli Studi dell'Insubria:
SARS-CoV-2
COVID-19
Saliva
nCoV-2019
Coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases